# K082601: UltraClot, UltraClot OTC

- Pathway: 510(k) (Traditional)
- Applicant: Emergency Medical Devices, LLC
- Decided: Oct 9, 2008 after 31 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002550 (2000). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013390: Quickclot, On Site Gas Systems, Inc. (2002) Summary page 5.
- K070010: Quikclot Sport and Quikclot Sport Silver, Z-Medica Corporation (2007) Summary page 5.
- K081183: Woundstat, Traumacure, Inc. (2008) Summary page 6.
- K061079: Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules, Medtrade Products, Ltd. (2006) Summary page 6.
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam, Hemostasis, LLC (2007) Summary page 6.
- K071578: Bloodstop and Bloodstop IX  Hemostatic Gauze, Models  BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, Bsix-15, Bsix-17, Lifescience Plus, Inc. (2007) Summary page 6.

## Indications for use
Prescription, Rx UltraClot is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding. Over the Counter, OTC UltraClot OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.

Source page: https://510kreport.com/device/K082601
Methodology: https://510kreport.com/methodology